GMP News Drug Safety/Pharmacovigilance

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 with regard to IMP labelling?

The FDA recently published its new draft guidance on Risk Evaluation and Mitigation Strategy (REMS). Read more about Format and Content of a REMS Document.